Last updated: 11/04/2018 13:49:37
Evaluation of a test mouthwash and dentifrice regimen in an in-situ model of dental erosion
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluation of a test mouthwash and dentifrice regimen in an in-situ model of dental erosion
Trial description: An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Adjusted mean percent net erosion resistance (NER) of enamel specimens exposed to test dentifrice + test MR relative to: 1) Test Dentifrice+ Sterile water rinse 2) Reference Dentifrice+ Sterile water rinse 3) Placebo Dentifrice+ Sterile water rinse
Timeframe: Baseline, 4 hours post treatment in each treatment period
Secondary outcomes:
Adjusted mean percentage surface microhardness (SMH) recovery of enamel specimens exposed to Test dentifrice + test MR relative to: 1)Test Dentifrice+Sterile water rinse 2)Reference Dentifrice+Sterile water rinse 3)Placebo Dentifrice+ Sterile water rinse
Timeframe: Baseline, 4 hours post treatment in each treatment period.
Interventions:
Drug: Sodium fluoride
Drug: Sodium monoflurophosphate
Drug: Sterile water
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
2009-31-10
Time perspective:
Not applicable
Clinical publications:
Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. J Dent. 2010 Nov;38 Suppl 3:S37-44
Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. J Dent. 2010 Nov;38 Suppl 3:S37-44
Medical condition
tooth erosion
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
August 2009 to October 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
- No current active caries or periodontal disease that may compromise the study or the health of the subjects
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Inclusion and exclusion criteria
Inclusion criteria:
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch
- subjects may have fixed bridges replacing missing teeth
- No current active caries or periodontal disease that may compromise the study or the health of the subjects
- A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute
Exclusion criteria:
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Trial location(s)
Location
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-31-10
Actual study completion date
2009-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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